Cromolyn Sodium Solution/ Drops Recall
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FDA Labeling Changes
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Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
There is currently no drug history available for this drug.
Cromolyn sodium ophthalmic solution USP, 4% is a clear, colorless, sterile solution for topical ophthalmic use.
Cromolyn sodium is represented by the following structural formula:
C23H14Na2O11 Mol. Wt. 512.34
Chemical Name: Disodium 5,5'- [(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]
Pharmacologic Category: Mast cell stabilizer.
EACH mL CONTAINS: ACTIVE: Cromolyn Sodium 40 mg (4%); INACTIVES: Edetate Disodium 0.1% and Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 - 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.